510(k) · Cleared
ClearedKelo-Cote Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Bio-Technologies, Inc. · MDA Elastomer, Silicone, For Scar Management
Cleared on Apr 14, 2006 as substantially equivalent to K002488 (Advanced Bio-Technologies, Inc., 2001) and 1 other predicate after a 121-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Apr 14, 2006
- Review
- 121 days
- Class
- Class I
- Product code
- MDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002338 (2001). 3 ancestors in all, the oldest K002488 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002338 | Liquiderm Liquid Adhesive Bandage | Closure Medical Corp. | 2001 | — |
| −1 | K022645 | CURAD | Beiersdorf AG | 2002 | — |
| 0 (this device) | K053481 | Kelo-Cote Spray | Advanced Bio-Technologies, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MDA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002488 | Kelo-Cote Topical GelSummary page 1…trauma wounds. Substantial Equivalence ABT believes Kelo-Cote Spray is substantially equivalent to legally marketed products: ABT's Kelo-Cote Topical Gel (K002488) and the Curad Spray Bandage (K022645). The ABT Kelo-Coat Topical Gel provides a substantial equivalence basis… | 2001 |
| * | K022645 | CURADSummary page 1…ABT believes Kelo-Cote Spray is substantially equivalent to legally marketed products: ABT's Kelo-Cote Topical Gel (K002488) and the Curad Spray Bandage (K022645). The ABT Kelo-Coat Topical Gel provides a substantial equivalence basis for the intended use and components… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K002488.
How does its category compare?
All MDA devicesMDA Elastomer, Silicone, For Scar Management: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDA
2in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · MDA
Too few MDA 510(k)s in any year since 2007 to give a median.
Recalls per year · MDA
No recall names MDA since 2007.
Adverse event reports per year · MDA
3in 2025
MAUDE reports naming product code MDA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Kelo-Cote Spray is a topical silicone spray intended for the management of old and new hypertrophic and keloid scarring on scars resulting from bums, general surgical procedures and trauma wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053481: Kelo-Cote Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053481
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026